External Manufacturing Operations Lead job in Bulle, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Operations Management

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

̽��ϼ� is seeking a dedicated and experienced Biological Contract Manufacturing Manager. The successful candidate will be responsible for interacting with biological Contract Manufacturers (CMOs) to ensure the supply of biological Drug Substances in the required quality, quantity, timing, and cost. This role also involves managing technical projects at CMOs and coordinating any associated required regulatory documentation.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

Interact with biological Contract Manufacturers to ensure supply of biological Drug Substances.
Support and manage technical projects at CMOs.
Ensure availability of up-to-date GMP documentation at CMOs.
Ensure efficient communication with CMOs and track production and technical transfer activities.
Manage deviation and change control in UCB system.
Monitor process performance at CMOs.
Perform regular risk analysis of the CMOs.
Define process improvement implementation roadmap in collaboration with internal functions and CMOs.
Lead project for implementation/modification of manufacturing processes and analytical methods at CMOs.
Write/review/approve regulatory documents as required.
Share information that can impact the product quality, process performance, and CMO management.

Key Skills and Requirements:

Familiarity with biological manufacturing processes, including fermentation and purification methods.
Skilled in cGMP quality and regulatory requirements in the manufacture of NBEs.
Understanding of analytical development for recombinant protein products.
Demonstrated ability to successfully manage project at senior level.
Skilled at writing and reviewing technical documentation.
Leadership skills, including training, coaching, and disciplinary enforcement.
Ability to work in a matrix environment.
Knowledge of financials and budgeting processes.
Ability to define and implement a strategy.
Critical thinking and decision-making skills.

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert on +41 61 508 7073 or S.Hubert@Proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽��ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽��ϼ� is acting as an Employment Agency in relation to this vacancy.